MAUDE Adverse Event Report: TELEFLEX INCORPORATED UROLIFT; IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM

Model Number	IPN924184
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon was performing surgery and using the urolift 2 implant cartridge, and it misfired.The cartridge was removed from the field and replaced with a new device.No patient harm.

• Brand Name: UROLIFT
• Common Device Name: IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 21216772
• Report Number: 21216772
• Device Sequence Number: 15650073
• Product Code: PEW
• UDI-Device Identifier: 10814932020343
• UDI-Public: (01)10814932020343(17)250913(10)73J2300437
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2024
• Report Date (Section F): 12/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN924184
• Device Catalogue Number: UL2-C
• Device Lot Number: 73J2300437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Date Report Sent to FDA: 12/27/2024